Registration Dossier
Registration Dossier
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EC number: 947-865-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June 1996 to 23 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Mean individual scores : 3-2-2-2-1.67-2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Mean individual scores : 1-0-0.33-0-0.33-0.33
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dioctyltin bis (2-EHMA), purity >98%
- IUPAC Name:
- Dioctyltin bis (2-EHMA), purity >98%
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- EC Number:
- 239-622-4
- EC Name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- Cas Number:
- 15571-58-1
- Molecular formula:
- C36H72O4S2Sn
- IUPAC Name:
- 8-Oxa-3,5-dithia-4-stannatetradecanoic acid, 10-ethyl-4,4-dioctyl-7-oxo-, 2-ethylhexyl ester
- Details on test material:
- Purity >98%
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2615 - 3446 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°c
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-h light/dark period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted, 0.5 mL on a 6.5 cm² area (1 x 1 inch).
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 12 days
- Number of animals:
- Four males and two females
- Details on study design:
- On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper. Each 0.5 mL dose was applied to an area of skin approximately 6.5 cm² under a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period. Each animal received a single, four-hour, semi-occluded exposure to the test material. At the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionised water. The application sites were observed for erythema, oedema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and once daily through day 11 if irritation persisted. Skin reactions were evaluated according to the OECD scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Mean individual scores : 3-2-2-2-1.67-2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Mean individual scores : 1-0-0.33-0-0.33-0.33
- Irritant / corrosive response data:
- Six and four rabbits had slight to moderate erythema and very slight oedema, respectively. Desquamation was noted for three animals. Oedema completely subsided by day 6 or earlier. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier. Desquamation was noted for three animals.
Any other information on results incl. tables
Primary dermal irritation study in albino rabbits Individual dermal scores |
|||||||||||
0.5 mL/site |
|||||||||||
|
|
|
Erythema |
|
Oedema |
||||||
Animal |
Sex |
Site |
0.5-1h |
24h |
48h |
72h |
Site |
0.5-1h |
24h |
48h |
72h |
20850 |
M |
A |
2 |
3 |
3 |
3 |
A |
0 |
1 |
1 |
1 |
20856 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20873 |
M |
A |
0 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20877 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20899 |
F |
A |
1 |
1 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20914 |
F |
A |
2 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
|
|
Total |
7 |
12 |
13 |
13 |
Total |
0 |
1 |
1 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
h = hours; M = Male; F = Female |
|||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study the test material is not irritating to the skin.
- Executive summary:
The skin irritation potential of the test material was investigated in a study which was conducted in accordance with the stamdardised guideline OECD 404, under GLP conditions.
During the study, they test material was applied undiluted on a patch on shaved rabbit skin. The exposure period was 4 hours.
The test material induced slight to moderate erythema on all rabbits and very slight oedema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.
Under the conditions of this study the test material was not irritating to the skin.
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